The Associate Director, Drug Safety Risk Management is primarily responsible for performing safety surveillance for designated investigational and/or post-marketing projects. He/she will perform individual and aggregate medical reviews, interpret the clinical significance of incoming adverse events reports and prepare individual or aggregate safety reports. He/she will assist in signal detection, evaluation and communication of safety trends.

Perform medical review of clinical trial and post-marketing individual case reports to ensure appropriateness of medical content and MedDRA coding and accurate assessment of reporting requirements including expectedness/labeledness. Provide articulate and scientifically valid medical assessment and pharmacovigilance comments for each case. Perform review of published literature for identification of valid adverse drug reaction reports per internal SOPs.

Prepare Analysis of Similar Events based on the results of database search. Participate in preparation of expedited and/or ad-hoc safety reports to regulatory agencies and partner companies.

Collaborate with Safety Operations to ensure compliance with world-wide Safety regulations and applicable company internal processes, SOPs, and Work Practices.

Serve as Drug Safety medical resource and provide oversight, continuous medical support, advice, training and mentoring regarding the medical aspects of case management to other team members within DSRM and if necessary, other departments. Educate and update DSRM and other departments about the safety profile of the assigned products on a regular basis.

In close collaboration with Safety Operations, propose, initiate and contribute to procedures for optimization of collection, documentation, follow up and coding of adverse events and improving medical review processes, workflow steps, reporting compliance, SOPs, Work Practices and audit preparations.

Assist the Director of Drugs Safety Risk Management in detection, evaluation and interpretation of safety signals and trends. Actively participate in analysis and interpretation of aggregate safety reports and if necessary, propose to revise Reference Safety Information (i.e. Company Core Data Sheet, Package Inserts, Investigator’s Brochures) and other safety review activities.

Provide authorship and/or review of safety sections of study protocols, IBs, ICFs, Clinical Study Reports, etc. Writing and/or assisting in preparation of PSURs, IND and EU Annual Safety Reports, Integrated Summary of Safety, Summary of Clinical Safety, Risk Management Plans and other safety related reports. Review and prepare medical documentation in response to internal and external safety-related queries and provide safety inputs and comments on Standard Response Letters regarding safety issues.

Participate in various safety committees, including the Product Safety Committee, the Core Safety Labeling Committee, and when needed, Clinical Team meetings to provide Drug Safety representation, background information, and advice regarding safety issues to support implementation of company projects.

M.D/PharmD degrees with minimum 6 years of relevant medical, pharmaceutical or biotechnology experience, including at least 4 years within drug safety.

Strong knowledge of US and international safety regulations and guidelines, reporting requirements, best pharmacovigilance practices, MedDRA and WHO DRUG coding dictionaries.

Past experience of authorship of aggregate safety reports (PSURs, ASRs, USPRs, IB updates, etc) is a must.

Previous experience with authorship of NDA/BLA enabling documents (ISS, SCS, RMPs) is strongly preferred.

Excellent scientific, clinical and analytical knowledge base along with strong time management, prioritization, organization and multitasking skills are required for success in this position.

People management and team building experience are highly desired.

Strong communication skills, including verbal and written skills as well as presentation and team-interaction skills are necessary.

Working knowledge of Microsoft Office and experience with using Safety Databases; ARISg experience is a plus.

Reports to Director, Drug Safety Risk Management.

InterMune is an equal opportunity employer.

Please reference requisition number: DS 07029 when applying for this position.